Fact CheckerSign in

NCT07168395Not yet recruiting

Pre-emptive RTO for An Early Detected Gastric Varices in CT/MR Angiogram Trial

Pre-emptive RTO for An Early Detected Gastric Varices in CT/MR Angiogram Trial (PRADA Trial)

Source: ClinicalTrials.gov · Last updated 2 Jul 2026

Brief summary (registry, in English)

A number of treatment modalities are currently in use for gastric variceal bleeding (GVB). Balloon-occluded, plug-assisted, and coil-assisted retrograde transvenous obliteration (RTO) procedures are described in the literature as treatments for GVB after a bleeding episode occurs. Preliminary data suggests that prophylactic treatment of gastric varices may improve patient outcomes compared to conservative management. This study aims to compare pre-emptive treatment of gastric varices with current recommended medical management in a randomized prospective study design. Eligible patients will be randomized to receive RTO or to continue conservative management. Patients will be followed for up to 2 years for comparison of clinical outcomes, including episodes of gastric variceal bleeding, overall survival and transplant-free survival, complications, and secondary interventions.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
68 (estimated)
First submitted
1 Sept 2025
Start date
Oct 2026
Primary completion date
Nov 2027
Lead sponsor
University of California, Los Angeles
NCT number
NCT07168395

What you commit to

  • Study type: Interventional
  • Planned participants: 68
  • From Oct 2026 to the primary completion date, Nov 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous TIPS, BRTO, CARTO or PARTO procedure

Other illness

  • Cardiac failure
  • Active variceal bleeding
  • History of gastroesophageal variceal bleeding
  • Malignancy

Age

  • Age \<18 years

Other

  • Patients with decompensated cirrhosis based on AASLD 2023 Practice Guidance (Kaplan et al)
  • No right jugular or right common femoral venous access
  • No portal vein flow
  • Life expectancy of less than 6 months

Who the study is looking for

  • Age \> 18 years
  • Patients with compensated cirrhosis with a higher risk of decompensation based on AASLD 2023 Practice Guidance (Kaplan et al) - no ascites with endoscopic visualization of varices
  • Confirmed diagnosis of gastric varices either through CT, MRI, or Endoscopy.
  • No imaging (LIRAD4 or 5) or tumor marker (AFP) evidence of HCC or other malignancy
  • MELD \< 20
  • First de novo RTO procedure
  • Taking NSBB
  • Patent internal jugular or right common femoral vein
  • Willing to provide the hepatology service information for F/U
  • No known diagnosis of hypercoagulopathy
  • Patent portal vein or portal vein cavernous transformation

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.